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Clinical Trial To Evaluate ANT-1207 In Subjects With Acne

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ANT-1207
Vehicle
Sponsored by
Anterios Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of moderate to severe facial acne
  • 15 to 40 papules and pustules, and 5 to 50 open and/or closed comedones
  • no presence of nodules
  • female subjects must be not pregnant and non-lactating

Exclusion Criteria:

  • presence of 1 or more nodules
  • use of topical steroids on the face 4 weeks prior and during the study
  • use of systemic corticosteroids 6 weeks prior and during the study
  • topical or systemic acne treatment in the 4 weeks prior to Baseline

Sites / Locations

  • Total Skin & Beauty Dermatology Center
  • International Dermatology Research
  • Palm Beach Esthetic Dermatology and Laser Center
  • Gwinnett Clinical Research Center Inc.
  • Dermatology Specialists Research, LLC
  • William Coleman III, MD, APMC
  • Grekin Skin Institute
  • The Dermatology Group, P.C.
  • Gramercy Park Dermatology
  • Skin Search of Rochester, Inc
  • Dermatology Consulting Services
  • Penn State Hershey Medical Center Department of Dermatology
  • Yardley Dermatology Associates
  • The Skin Wellness Center
  • DermResearch, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Control

Dose 1

Dose 2

Dose 3

Dose 4

Arm Description

blank vehicle formulation

Dose 1

Dose 2

Dose 3

Dose 4

Outcomes

Primary Outcome Measures

Efficacy will be assessed by lesion count.
inflammatory lesion count (papules, pustules, and nodules) and non-inflammatory lesion count (open and closed comedones)

Secondary Outcome Measures

Change from Baseline in Investigator Global Assessment Score
Change from Baseline in Lesion Count

Full Information

First Posted
February 9, 2011
Last Updated
June 28, 2013
Sponsor
Anterios Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01293552
Brief Title
Clinical Trial To Evaluate ANT-1207 In Subjects With Acne
Official Title
Clinical Trial To Evaluate Botulinum Neurotoxin Type A (ANT-1207) In Subjects With Acne
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anterios Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 in the treatment of acne.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
blank vehicle formulation
Arm Title
Dose 1
Arm Type
Experimental
Arm Description
Dose 1
Arm Title
Dose 2
Arm Type
Experimental
Arm Description
Dose 2
Arm Title
Dose 3
Arm Type
Experimental
Arm Description
Dose 3
Arm Title
Dose 4
Arm Type
Experimental
Arm Description
Dose 4
Intervention Type
Biological
Intervention Name(s)
ANT-1207
Intervention Description
single dose application
Intervention Type
Biological
Intervention Name(s)
Vehicle
Other Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Efficacy will be assessed by lesion count.
Description
inflammatory lesion count (papules, pustules, and nodules) and non-inflammatory lesion count (open and closed comedones)
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Change from Baseline in Investigator Global Assessment Score
Time Frame
Week 1, 2, 4, 8, and 12
Title
Change from Baseline in Lesion Count
Time Frame
Week 1, 2, 4, 8, 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of moderate to severe facial acne 15 to 40 papules and pustules, and 5 to 50 open and/or closed comedones no presence of nodules female subjects must be not pregnant and non-lactating Exclusion Criteria: presence of 1 or more nodules use of topical steroids on the face 4 weeks prior and during the study use of systemic corticosteroids 6 weeks prior and during the study topical or systemic acne treatment in the 4 weeks prior to Baseline
Facility Information:
Facility Name
Total Skin & Beauty Dermatology Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
International Dermatology Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Palm Beach Esthetic Dermatology and Laser Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Gwinnett Clinical Research Center Inc.
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Dermatology Specialists Research, LLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
William Coleman III, MD, APMC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Grekin Skin Institute
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
The Dermatology Group, P.C.
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
Facility Name
Gramercy Park Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Skin Search of Rochester, Inc
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Dermatology Consulting Services
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Penn State Hershey Medical Center Department of Dermatology
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Yardley Dermatology Associates
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Facility Name
The Skin Wellness Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial To Evaluate ANT-1207 In Subjects With Acne

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